Trial | NCT01113372  Report issue

Title

Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial
Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3119
Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected patients from the "real-world" clinical practice receiving the Endeavor ZES for the treatment of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day for 3 months versus 12 months.
Study Started
Apr 30
2010
Primary Completion
Feb 28
2013
Study Completion
Jul 31
2015
Last Update
Dec 18
2015
Estimate

Drug Clopidogrel

Clopidogrel 75mg daily.

Clopidogrel 3 months Experimental

Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.

Clopidogrel 12 months Active Comparator

Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.

Criteria 

Inclusion Criteria:

patients >18 years of age,
clinical indication for PCI with stent implantation of at least one angiographically documented coronary artery lesion,
agreement to undergo all protocol clinical follow-ups. 4 - presence of at least one obstruction >50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with coronary anatomy suitable for percutaneous treatment with implantation of the Endeavor ZES.

Exclusion Criteria:

ST-elevation acute MI presenting for primary or rescue PCI;
DES in-stent restenosis;
PCI with bare metal stents <6 months prior to index procedure;
previous treatment with any DES;
scheduled elective surgery within 12 months post index procedure;
contra-indication, intolerance, or known hypersensibility to aspirin and/or clopidogrel;
known illness with life expectancy <36 months; and impossibility to comply with all protocol follow-ups.
target lesion(s) located in saphenous vein grafts,
coronary anatomy unsuitable for percutaneous treatment with implantation of the Endeavor ZES.
No Results Posted